Liability for defective devices Supreme Court: Consumers win right to sue makers of faulty medical products.

July 20, 1996

GOOD PRODUCT liability law is always a delicate balance between the rights of consumers to be protected from dangerous or faulty products and the protection of manufacturers from frivolous claims. When the product in question is a medical device, the passions aroused by faulty products can be especially intense.

Before ending its most recent term, the Supreme Court gave consumers an important victory, ruling that federal regulation of medical devices does not necessarily protect the manufacturers from liability. The government's power to regulate medical devices dates only to 1976, when Congress charged the Food and Drug Administration with overseeing medical devices. For regulatory purposes, these devices fall into three categories. Most life-sustaining devices, such as pacemakers or kidney dialysis machines, fall into Category III, which requires approval from the FDA providing "reasonable assurance" that they are safe and effective.

The 1976 law, however, provided exceptions for devices already on the market or for new devices that were substantially similar to existing devices. A pacemaker that failed in a Florida woman, prompting emergency surgery to save her life, provided a case testing whether this FDA oversight was enough to protect manufacturers from being sued.

The Supreme Court agreed that the federal law regulating the pacemaker does not necessarily protect the manufacturer from lawsuits. However, five justices did agree that such suits would be more difficult for devices that, unlike the pacemaker in question, were specifically reviewed by the FDA.

The ruling is expected to clear the way for more lawsuits from people claiming personal injury from medical devices. It may also highlight the fact that regulation by the FDA, often derided as overly burdensome, does have the advantage of providing manufacturers with valuable protection in the courtroom.

Pub Date: 7/20/96

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